Medical Manufacturing Compliancy:The Importance of Equipment Selection

Matt ZelkovichGeneral Manager, Conair MedLine ProductsConairmzelkovich@conairgroup.com | 480.266.5756

Medical Manufacturing Compliancy:What we’ll cover:

• Medical equipment use locations.

• Regulatory overview for medical devices and components.

• Why ISO 14644 cleanroom levels require different considerations.

• Review of typical environments for medical manufacturing.

• Equipment considerations within each environment.

• Summary of those requirements and its importance.

Medical equipment considerationsIdentify the equipment use location:

This choice will help clarify specifications. • Four most common types of clean room:

White room: ISO 8 clean room ISO 7 clean room Hybrid clean room

Regulatory overviewRegulatory and ISO compliancy:• ISO 14644 Cleanrooms and associated controlled

environments• ISO 9001: Continuous improvement quality standards

– Implementing and documenting continuous improvement• ISO 13485: Medical device quality & risk standards

– Validated processes are typically implemented• FDA 21CFR and ICH standards: Pharmaceutical quality

standards CFR Code of Federal Regulations – Part 11 , Part 210,& 211 cGMP (Current good manufacturing

practices), Part 820 quality system regulation• ISO 17025: Calibration standards

White Room: A non-controlled, air-conditioned environment with no particulate or air change-over control.

ISO 14644 for the plastics industry

• Operated like a cleanroom.• Requires gowning, hairnets and shoe covers .• Typical entry level environment.• Uses “standard equipment”.• Focus is on cleanliness and compliancy.• Calibrations, preventative maintenance, and

installation qualifications are becoming commonplace.

Equipment use location: White Room

ISO 8 (class 100,000): Cleanrooms that require the reduction of particulate generation from equipment and staff.

ISO 14644 for the plastics industry

• Air turnover rate of 5 to 48 times per hour.• Particulate levels in compliance to Standards:

≥ 0.5µm (3,520,000) ≥ 5 µm (29,300)• Equipment should be designed for this environment.• ISO 8 rooms are commonly ISO 9001, or 13485 certified:• Non-particulate-generating materials are considered and

used when possible.

Equipment use location: ISO 8 clean room

ISO 7 (class 10,000): MORE stringent than ISO 8.

ISO 14644 for the plastics industry

• Air turnover rates of 60 to 90 times per hour: • Particulate levels in compliance to Standards:

≥ 0.5µm (352,000) ≥ 5 µm (2,930)• Medical manufacturing humidity control:

Helps control static electricity and bacteria growth.• Equipment needs to match this more stringent environment:

Stainless steel housings, castings, and covers VS anodized aluminum. Gasket materials changed to FDA compliant gaskets, plenum-rated cabling.

Equipment use location: ISO 7 clean room

Hybrid cleanroomsTypically driven by cost considerations againstproduct cleanliness requirements.

ISO 14644 for the plastics industry

• Particulate levels in compliance to the chosen standards; from ISO 8, down to ISO 6.

• Equipment can be located outside the room. • Equipment can be standard.• No need for costly materials for inside cleanroom.• Compliancy such as calibrations, preventative

maintenance, and installation qualifications are still required.

Equipment use location: Hybrid room

Equipment Selectionfor Medical Manufacturing clean rooms

Equipment selection for White Rooms

White rooms are often ‘entry-level clean rooms’ for manufacturers preparing for more rigorous compliance.

Auxiliary equipment commonly selected for White rooms:• ‘Standard’ auxiliary equipment is commonly

acceptable.• Medical cleanliness requirements are enforced.• Calibration and PM schedules more stringent.• Calibration and PM schedules must be

documented.

Equipment selection for White Rooms

Equipment selection for ISO 8 clean rooms

ISO 8 rooms are the ‘most common cleanrooms’ for medical manufacturers.

Auxiliary equipment commonly selected for ISO 8 clean rooms:• Powder-coated medical finishes.• Constructed of non-ferrous metals:

o Anodized & plated aluminum.• Minimized exhaust or routed outside of room.• Tool-less and contaminent-free maintenance designs.• Fully documented calibration and preventative maintenance.

Equipment selection for ISO 8 clean rooms

Equipment selection for ISO 7 clean rooms

ISO 7 rooms are the ‘more stringent cleanrooms’ for medical manufacturing.

Equipment commonly selected for ISO 7 clean rooms:• Water cooled in place of air cooled.• Gasket materials being FDA-approved, non shedding

construction.• Minimized exhaust and fume or routed outside of room.• Tool-less and contaminant-free maintenance designs.• Auxiliaries calibration, PM and IQ requirements.

Equipment selection for ISO 7 clean rooms

Equipment selection for Hybrid rooms

Hybrid clean rooms are typically a ‘balance between cost and cleanliness specifications’ for medical manufacturers.

Equipment selection for Hybrid rooms

Auxiliary equipment commonly selected for Hybrid clean rooms:• Calibrations, PM, and installation qualifications are required,

but:o Equipment can be located outside the room. o Equipment can be standard.

• Compliance requirements range from ISO 8 to ISO 6.• Specific compliance requirements are commonly negotiated

between the manufacturer and their customer.

• Over 170 variations of auxiliary equipment designed specifically for medical applications.

Importance of equipment selection:• Drying

• Material conveying

• Heat transfer

• Blending/Feeding

• Downstream

extrusionConair MedLine®

equipment: Cleanroom ready

• Over 40 models of auxiliary equipment designed specifically for medical applications.

Summary:• Choosing the right equipment for the manufacturing environment

and proper preparation up front allows easier management of the environment while maintaining cleanroom specifications much more efficiently.

• It’s all about maintaining the particulate levels below the standards of your environment. So selection of everything you put into that environment is very important.

• New ISO 14644 releases for -1 and-2 are moving toward more continuous monitoring of plastic manufacturing environments.

• The demand for cleaner medical products is being scrutinized more every day.

Thank You!

Implementing the right equipment into your environments allows you to meet standards and regulations and will help you run more efficiently, reduce risk, manage your cleanrooms much easier, saving you money and ultimately attracting you more business… This is why it matters!

Matt ZelkovichGeneral Manager, Conair MedLine productsmzelkovich@conairgroup.com480.266.5756